Clinical research from proposal to implementation: what every clinical investigator should know about the institutional review board.
The conduct of clinical trials is a complicated process involving a myriad of regulations and enforcement entities. To protect the rights and welfare of study participants, a system of oversight bodies called institutional review boards has been established in the US. This article describes how institutional review boards work and explains what clinical researchers need to know about federally mandated human subject protection requirements.
Rivera
Suzanne M
SM
From the UT Southwestern Medical Center, Dallas, TX. suzanne.rivera@utsouthwestern.edu
D035843:Biomedical Research; D002986:Clinical Trials as Topic; D003219:Confidentiality; D028744:Ethics Committees, Research; D006801:Humans; D007348:Insurance, Health